Key Highlights

  • Diluted EPS was USD 0.05 against an estimate of USD -0.45, and Net Income was USD 3.9 million.
  • Loss from operations was USD 6.3 million, while total other income was USD 10.3 million on Warrant and derivative changes.
  • A new drug application seeking Accelerated Approval of CNM-Au8 in ALS was submitted in October 2026.
  • Cash was USD 9.9 million at September 30, and management said additional financing is needed within twelve months.

Clene Inc. (NASDAQ:CLNN) is a clinical-stage company whose lead drug candidate is CNM-Au8. In October 2026 it submitted a new drug application to the U.S. Food and Drug Administration seeking accelerated approval for amyotrophic lateral sclerosis (ALS). Third quarter Revenue was USD 0.056 million against an estimate of USD 0.07 million, and diluted EPS was USD 0.05 against an estimate of a USD 0.45 loss.

The ALS Filing and Pipeline Priorities

The application is supported by neurofilament light chain biomarker data and clinical outcomes from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, the Phase 2 RESCUE-ALS trial and an expanded access protocol sponsored by the National Institutes of Health. Management said an FDA response on whether the application is accepted for review is awaited before the end of 2026, and that a Phase 3 RESTORE-ALS trial is planned to begin in the second quarter of 2027 as the post-approval confirmatory study.

In multiple sclerosis, the company met with the FDA in the third quarter of 2025 about a planned Phase 3 study focused on cognition as an adjunct to standard therapies. The agency expressed openness to endpoints other than the Expanded Disability Status Scale, and management said it believes licensing opportunities for the MS indication improve once another indication is approved. Dietary supplement sales and royalties produced product revenue of USD 0.043 million and Royalty revenue of USD 0.013 million.

Financial Results for the Quarter

Total revenue was USD 0.056 million against USD 0.015 million a year earlier. Research and Development expense was USD 4.45 million against USD 3.51 million, and general and administrative expense was USD 1.94 million against USD 2.15 million. The loss from operations was USD 6.35 million against USD 5.65 million.

Net income was USD 3.92 million against a net loss of USD 8.78 million, with other income of USD 10.26 million. That included a USD 7.49 million gain from the change in Fair Value of common stock warrant liabilities and a USD 3.37 million gain from derivative liabilities, against losses of USD 1.73 million and USD 0.80 million a year earlier. Basic EPS was USD 0.30 and diluted EPS was USD 0.05, against a loss of USD 0.85 per share a year ago.

Funding, Going Concern and Capital Raised

Cash and cash equivalents were USD 9.9 million at September 30, against USD 5.2 million at year end 2025, and net cash used in Operating Activities over nine months was USD 11.7 million against USD 13.7 million. Management said the company lacks sufficient cash to sustain current operations for the next twelve months unless it obtains additional financing, and the statements were prepared on a going concern basis.

Capital raised in 2026 included a May sale of 1,000,000 shares at USD 7.00 per share and a September sale of 1,219,513 shares at USD 3.28 per share for gross proceeds of USD 4.0 million.

Balance Sheet and Cash Markers

Cash of USD 9.9 million sits alongside quarterly operating expenses of USD 6.4 million, a nine-month operating cash outflow of USD 11.7 million and an accumulated Deficit of USD 325.9 million. Net income of USD 3.9 million compares with a loss from operations of USD 6.3 million.

Management named a short list of items: the FDA's acceptance decision on the application before the end of 2026, the Phase 3 RESTORE-ALS start in the second quarter of 2027, and efforts to raise additional funds through equity, debt, licensing or collaboration arrangements, the at-the-market Facility and warrant and option exercises. General and administrative expenses would increase if the FDA accepts the application.